FDA 483 - UConn Health John Dempsey Hospital - August 20, 2010

John Dempsey Hospital in Farmington, CT, received a Form 483 following an FDA inspection, citing two observations related to its blood bank operations. The findings indicate deficiencies in maintaining complete quality control testing records for blood and blood component irradiation, as well as a failure to consistently adhere to written standard operating procedures for blood irradiator operation. These issues highlight concerns with documentation practices and procedural compliance within the facility.